ENZYMATIC CHOLESTEROL— 510(k) K810673
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K810673 for ENZYMATIC CHOLESTEROL, Substantially Equivalent on 1981-03-31. Applicant: Pointe Scientific, Inc.,. Device class: 1.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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